This three-part, Phase 1 protocol will be the first clinical study of ABI-H2158. Parts 1 and 2 will be a Phase 1a, dose-ranging assessment of ABI-H2158 in healthy adult volunteers. If the dose-related safety, tolerability, and pharmacokinetics (PK) of ABI-H2158 in healthy volunteers are deemed satisfactory, then the study will advance to Part 3, a Phase 1b, dose-ranging assessment of ABI-H2158 in non-cirrhotic, CHB patients.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
Enrollment
80
5 mg or 25 mg tablets
Sugar pill manufactured to mimic the ABI-H2158 5 mg or 25 mg tablets
Southern California Research Center
Coronado, California, United States
Research and Education
San Diego, California, United States
Quest Clinical Research
San Francisco, California, United States
Number of healthy volunteers and patients with chronic HBV infection with treatment-related adverse events as assessed by CTCAE v4.0.
Time frame: Up to 28 days
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Infectious Disease Care
Hillsborough, New Jersey, United States
Monash University
Clayton, Victoria, Australia
The Alfred Hospital
Melbourne, Victoria, Australia
Linear Clinical Research
Nedlands, Western Australia, Australia
First Hospital of Jilin University
Jilin City, Changchun, China
University of Hong Kong, Queen Mary Hospital
Hong Kong, Hong Kong
Auckland Clinical Studies
Auckland, New Zealand
...and 4 more locations